Apparatus for automatically inflating a vascular balloon catheter and system for performing angioplasty - Patent Application 20070122997

Abstract

The present invention relates to a device (4) for automatically inflating a vascular balloon catheter (6) with a fluid, the device (4) comprising a catheter interface (8), a fluid supply device (12), a pressure sensor device (16), and a control device (18). The catheter interface (8) is particularly designed to be removably connectable to the balloon catheter (6) without tools, thereby allowing fluid to flow from the device (4) to the balloon catheter (6) via the catheter interface (8). The fluid supply device (12) is designed to discharge fluid from the device (4) at the catheter interface (8) by a motor (32). The pressure sensor device (16) is designed to measure the pressure of the fluid discharged from the device (4). The control device (18) is designed to control the amount of fluid discharged from the device (4) by the fluid supply device (12) by driving the motor (32) of the fluid supply device (12) based on the pressure measured by the pressure sensor device (16). According to the present disclosure, the fluid supply device (12) is designed to allow fluid to be drawn into the device (4) at the catheter interface (8) by a motor (32). The present disclosure further relates to a system (2; 102; 202; 302) for performing angioplasty, comprising a balloon catheter (6) and a device (4) according to the present disclosure.

Description

[Technical Field]

[0001] The present disclosure relates to a device for automatically inflating a vascular balloon catheter, particularly an angioplasty catheter and a percutaneous transluminal angioplasty catheter, respectively (for PTA: percutaneous transluminal angioplasty or PTCA: percutaneous transluminal coronary angioplasty), with a fluid. The device includes a catheter interface, a fluid supply device, a pressure sensor device, and a control device. The catheter interface is particularly designed for detachable connection to the balloon catheter without tools, so that fluid can flow from the device to the balloon catheter via the catheter interface. The fluid supply device is designed at the catheter interface to allow a motor to eject liquid from the device. The pressure sensor device is adapted to measure the pressure of the fluid ejected from the device. The control device controls the motor of the fluid supply device to control the amount of fluid ejected from the device by the fluid supply device as a function of the pressure measured by the pressure sensor device. The present disclosure further relates to a system for performing angioplasty, comprising a device according to the present disclosure and a balloon catheter. [Background technology]

[0002] A typical device is disclosed, for example, in EP 0 490 979 B1. The conventional device comprises a catheter interface, a fluid supply device, a pressure sensor device, and a control device. The fluid supply device is adapted to supply fluid to a balloon catheter via the catheter interface. To control the inflation of the balloon catheter, or more specifically the balloon of the balloon catheter, the pressure of the balloon catheter, or more specifically the balloon, can be measured by a pressure sensor device. The control device is adapted to control the fluid supply device as a function of the pressure measured by the pressure sensor device. To be able to supply fluid from the balloon catheter, the conventional device comprises a piston syringe that can only be operated manually.

[0003] During angioplasty, the balloon of the balloon catheter is inflated, interrupting the blood supply. A problem with conventional devices is that if the interruption in blood flow is too long and excessive pressure is generated in the balloon catheter, the excess fluid that is creating the excessive pressure can only be removed from the balloon catheter after a certain time delay.

[0004] CN108096676A discloses a tracheal catheter, i.e., a catheter for the trachea, whose balloon operates at an overpressure of about 25-30 mbar.

[0005] DE 102005060197 A1 discloses a completely implanted device, which does not allow the balloon catheter to be evacuated, since the evacuated gas would be pumped back into the balloon when it is inflated. Furthermore, the catheter is a flushing catheter with a latex balloon that operates with only a minimal overpressure of a few millibars.

[0006] DE 10 2014 003 306 A1 discloses a balloon catheter for transanal irrigation, which also does not have an exhaust valve.

[0007] US20070197963A1 discloses a device for applying a previously evacuated balloon catheter. This device is not intended or capable of evacuating a balloon catheter, primarily because it uses a peristaltic pump. However, such a pump cannot generate a vacuum because the peristaltic tubing does not "rearrange itself" when negative pressure builds up. However, if the tubing is made stiff to achieve this characteristic, it will no longer compress and, as a result, will not be able to pump. The peristaltic pump can only generate minimal negative pressure. According to US20070197963A1, only the balloon of the balloon catheter is evacuated, not the catheter itself. Summary of the Invention

[0008] It is therefore an object of the present invention to provide a device for automatically inflating a balloon catheter, which makes it possible to minimize the period of interruption of the blood supply and / or to reduce the amount of liquid in the balloon catheter in a timely manner.

[0009] This object is solved by an apparatus comprising the features of claim 1 and by a system comprising the features of claim 14. Advantageous further developments are the subject of the subclaims.

[0010] The device according to the present disclosure is suitable for automatically inflating a balloon catheter with a fluid. The fluid may be a liquid, particularly saline, and / or a contrast agent. Examples of contrast agents include iopromide, iodixanol, ioxaglate, iohexol, iopamidol, iomeprol, iomeron, gadodiamide, or gadolinium. For dilution, the contrast agent is preferably diluted with saline, e.g., 0.9% NaCl. Gadodiamide or gadolinium may be used as a stock solution. A suitable mixing ratio of contrast agent to diluent is 1:1 to 1:3, preferably about 1:2.

[0011] The device includes a catheter interface, a fluid supply, a pressure sensor, and a controller.

[0012] The catheter interface is particularly designed to be removably connectable to the balloon catheter without tools, thereby allowing fluid to flow from the device through the catheter interface to the balloon catheter. The catheter interface may particularly be designed as a Luer connection.

[0013] The fluid delivery device is designed at the catheter interface so that fluid can be motorized out of the device.

[0014] The fluid supply device can be designed in particular as a piston syringe, the piston of which can be connected to a motor so that it can be moved by the motor. The motor can be configured as a linear motor that directly transmits linear motion to the piston. Alternatively, the motor can be designed as a rotary motor. In this case, a transmission device can be provided that converts the rotary motion of the motor into linear motion and displaces the piston.

[0015] Optionally, other methods of transmitting linear motion of the piston may be used, such as a toggle lever, a scissor joint, or a lever structure for converting the rotary motion of the motor into linear motion of the piston.

[0016] The motor may in particular be an electric motor, a mechatronic motor, a pneumatic motor or a hydraulic motor.

[0017] The pressure sensor device is adapted to measure the pressure of the fluid being discharged from the device. In particular, the pressure sensor device may be adapted to measure the pressure of the fluid being discharged from the device at the catheter interface, and / or at the piston of a piston syringe, and / or at any other suitable location. Preferably, the pressure sensor (as part of the pressure sensor device) may be provided at the catheter interface, in particular outside the device, where the pressure sensor is in fluid communication with the balloon catheter or the balloon of the balloon catheter when the balloon catheter is connected to the device or more particularly to the catheter interface of the device. The pressure sensor device or pressure sensor may be connected to the control device by cable or wirelessly.

[0018] The control device is adapted to drive the motor of the fluid supply device to control either directly (by monitoring the amount) or indirectly (by monitoring the delivery rate of fluid delivered by the fluid supply device) the amount of fluid discharged from the device by the fluid supply device as a function of the pressure measured by the pressure sensor device. In particular, the control device may be designed to deliver a corresponding amount of fluid from the device to the balloon catheter to reach a predetermined target pressure in the balloon catheter or in the balloon of the balloon catheter.

[0019] According to the present disclosure, the fluid delivery device is designed at the catheter interface so that fluid can be drawn into the device by a motor.

[0020] In other words, the fluid supply device is designed to optionally supply fluid from the device to the balloon catheter, or more specifically the balloon of the balloon catheter, or to deliver fluid from the balloon catheter, or more specifically the balloon of the balloon catheter, to the device, when the balloon catheter is connected to the device, or more specifically the catheter interface of the device.

[0021] The device may form a closed system with the balloon catheter when connected to the balloon catheter, i.e., fluid is transferred only between the device and the balloon catheter as needed. Alternatively, the device may form an open system with the balloon catheter when connected to the balloon catheter. In particular, in the case of an open system, the device may have a fluid inlet for connecting the device to a fluid source and a fluid outlet for connecting the device to a fluid drain.

[0022] The device of the present disclosure is designed to allow fluid to be expelled or withdrawn at will by the delivery device, thereby advantageously allowing for rapid changes in the volume of the balloon of the balloon catheter during angioplasty.

[0023] The device disclosed in the present invention is capable of first evacuating the balloon catheter, i.e., applying a strong negative pressure to the balloon catheter to remove any residual air remaining in the balloon catheter after cleaning it, and in particular to prevent the residual air from re-entering the balloon catheter. Air can hinder inflation and is particularly dangerous if the balloon catheter ruptures. This is because, unlike inflation fluid, residual air in a balloon catheter will expand explosively at pressures of 10 bar or more, and in the worst case, can damage or even rupture the blood vessel. In addition, air in the blood vessel can lead to thrombosis.

[0024] The delivery device may be designed to expel fluid at a rate of 0.33 ml / sec or greater (1 ml / sec) and draw fluid at a rate of 10-15 ml / sec.

[0025] According to one aspect of the present disclosure, the control device can be designed to draw fluid through the fluid supply device when a predetermined threshold of pressure measured by the pressure sensor device is exceeded. The predetermined threshold can correspond to a target pressure to be provided during proper performance of an angioplasty procedure. Alternatively, the predetermined threshold can be greater than the target pressure such that an acceptable or target pressure range for performing an angioplasty procedure at the target pressure and the predetermined threshold is defined.

[0026] Safety during angioplasty can be enhanced if a predetermined threshold is identified that automatically withdraws fluid when exceeded.

[0027] According to one aspect of the present disclosure, the control device can be designed to prevent fluid from being drawn in by the fluid supply device after a predetermined threshold has been exceeded and after a subsequent drop in pressure measured by the pressure sensor device upon re-reaching the predetermined threshold.

[0028] If the device is designed so that fluid withdrawal begins only when a predetermined threshold is exceeded, it is advantageous to reduce or completely eliminate excessive stress on the body tissue of the body cavity during operation of a balloon catheter connected to the device, without unduly reducing the force required to expand the body cavity.

[0029] According to one aspect of the present disclosure, the fluid may be a liquid, and the device may include an exhaust device by which gas mixed with the liquid can be expelled from the device. The exhaust device may be provided in particular in the catheter interface. Alternatively, the exhaust device may be formed in the fluid supply device.

[0030] When a liquid is used to inflate the balloon catheter, the transmission of force from the motor to the tissue to be expanded via the fluid can be improved, and when an exhaust device is provided, this improved transmission of force can be ensured in an advantageous manner.

[0031] According to one aspect of the present disclosure, the controller may be capable of or designed to control the fluid delivery device so that fluid is delivered at different predetermined delivery rates. In particular, different target delivery rate profiles may be stored in the controller. Preferably, the delivery rate during fluid retraction may be greater than the delivery rate during fluid expulsion.

[0032] If different predetermined delivery rates are provided, the response time of the device can be appropriately adjusted for different demands during angioplasty.

[0033] According to one aspect of the present disclosure, the control device may be designed to adjust the fluid supply device based on the pressure measured by the pressure sensor device. In particular, the control device may be designed to allow the pressure measured by the pressure sensor device to reach at least two different predetermined pressure levels. Preferably, the different pressure levels and / or predetermined sequences of pressure levels may be stored in the control device.

[0034] According to one aspect of the present disclosure, the device may include an energy storage device (for storing electrical or mechanical energy) to not only reduce excess pressure but also regenerate vacuum in the event of a power outage, thereby allowing the balloon catheter to be deflated and / or withdrawn even in the event of a power outage.

[0035] According to one aspect of the present disclosure, the motor of the fluid supply device may have tensioning means designed to tension when fluid is expelled and to relax when fluid is retracted. The tensioning means may in particular be a spring, preferably a compression spring. In particular, the fluid supply device may be designed as a piston syringe, and the compression spring may be provided or attached to the piston of the piston syringe such that the compression spring is tensioned when the piston is moved (by the motor) to expel fluid from the piston syringe and the compression spring is relaxed when the piston is moved to retract fluid into the piston syringe.

[0036] The operational safety of the device can be improved if the motor is provided with tensioning means, which can draw fluid into the device if the power supply to the motor is interrupted.

[0037] According to one aspect of the present disclosure, the control device may have a data interface that may be designed to transfer data to and / or from a smartphone, tablet, or other device, particularly a medical device. In particular, the data interface may be adapted to allow a wired or wireless connection to the smartphone, tablet, or other medical device. Preferably, the data interface may be designed to allow a connection using a communication standard such as USB, Wi-Fi, NFC, Bluetooth (BT), or Bluetooth Low Energy (BLE).

[0038] Alternatively, the data interface may be configured as a pressure connection and the controller may be designed to control the fluid supply device in response to pressure measured at the pressure connection.

[0039] When a data interface is provided, operation and / or monitoring of the device according to the present disclosure can be performed in a cost-effective manner.

[0040] According to one aspect of the present disclosure, the device may include a manipulation device connected to the control device or, more specifically, to the data interface, and adapted to receive control commands from a person and transmit the control commands to the control device. The manipulation device may be connected to the control device or the data interface by wire or wirelessly.

[0041] If the device is equipped with an operating device, the operability of the device independent of peripheral devices can be advantageously protected.

[0042] According to one aspect of the present disclosure, the operating device may be designed as a manual inflation syringe. In particular, the operating device may have a pistol grip or a toggle-shaped handle. Preferably, the operating device may have a slide switch or a toggle switch, by which a predetermined threshold value for the pressure of the expelled fluid and / or a target pressure can be specified.

[0043] If the operating device is designed in the form of a manual inflation syringe, familiarity with the device according to the present disclosure is facilitated.

[0044] According to one aspect of the present invention, the operating device may be an inflation syringe or a piston syringe by which a control fluid can be supplied to a control fluid interface of the inflation syringe or piston syringe by movement of a piston, the device may have a pressure connection designed to be connected to the control fluid interface of the inflation syringe or piston syringe, the pressure sensor device may be particularly designed to measure the pressure of the control fluid at the pressure connection, and the control device may be adapted to control the fluid supply device based on the pressure of the control fluid measured at the pressure connection, in particular. The control fluid interface may be particularly configured as a Luer connection.

[0045] If the data interface is designed as a pressure connection compatible with the control fluid interface of an inflation syringe or piston syringe, the operating device can be implemented in a cost-effective manner.

[0046] According to one aspect of the present disclosure, the operating device may have a display adapted to display status data of the device. In particular, the operating device may be designed as a touch screen.

[0047] Furthermore, the present disclosure relates to a system for performing angioplasty, in particular percutaneous transluminal angioplasty (PTA) or percutaneous transluminal coronary angioplasty (PTCA), comprising a balloon catheter and a device according to the present disclosure.

[0048] According to one aspect of the present disclosure, the device may be designed to generate negative pressure or vacuum in a balloon catheter (i.e., in the balloon of the balloon catheter and / or in the catheter) to expel gas or liquid in the catheter from the catheter. [Brief explanation of the drawings]

[0049] The invention will now be described in more detail with reference to preferred embodiments and with reference to the accompanying drawings, in which: [Figure 1] 1 shows a schematic diagram of a system according to a first embodiment of the present invention; [Figure 2] 1 is a schematic diagram of a fluid supply device according to the present invention; [Figure 3] 2 shows a schematic diagram of a system according to a second embodiment of the present invention; [Figure 4] 3 shows a schematic diagram of a system according to a third embodiment of the present invention. [Figure 5] 1 shows a schematic diagram of an electric operating device according to a first embodiment of the present invention. [Figure 6] 4 shows a schematic diagram of an electric operating device according to a second embodiment of the present invention. [Figure 7] FIG. 10 shows a schematic diagram of an electric operating device according to a third embodiment of the present invention. [Figure 8] 10 shows a schematic diagram of a system according to a fourth embodiment of the present invention. [Figure 9] 1 is a schematic diagram of a fluid machine operating device according to a first embodiment of the present invention, showing a quick release valve in an inactive position; [Figure 10] 1 is a schematic diagram of a fluid machine operating device according to a first embodiment, showing a quick release valve in an active position. [Figure 11] FIG. 3 is a schematic diagram of a fluid machine operating device according to a second embodiment of the present invention. [Figure 12] 10 shows a schematic diagram of a fluid machine operating device according to a third embodiment of the present invention, with a quick release valve in an inactive position. [Figure 13] 10 is a schematic diagram of a fluid machine operating device according to a third embodiment of the present invention, showing a quick release valve in an active position. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0050] FIG. 1 shows a schematic diagram of a system 2 according to a first embodiment of the present disclosure, comprising a device 4 and a balloon catheter 6 .

[0051] The device 4 comprises a catheter interface 8 in the form of a three-way valve 10, a fluid supply device 12 in the form of an electric piston syringe 14, a pressure sensor device 16, a control device 18 and two operating devices 20, 22. The catheter interface 8 does not have to be designed as a three-way valve 10 but can also be formed, for example, by a simple valve.

[0052] The catheter interface 8, i.e., the three-way valve 10, is designed so that the balloon catheter 6 can be connected to the catheter interface 8 and the three-way valve 10, respectively, without tools, and can be disconnected from the catheter interface 8, or more specifically, the three-way valve 10, without tools. The three-way valve 10 has three connection points 24, 26, 28. The connection point 24 is formed as a Luer connection point that is specifically adapted to a Luer connection point of the balloon catheter 6.

[0053] The connection point 26 is fluid-mechanically connected to the piston syringe 14 of the fluid supply device 12 .

[0054] Connection point 28 is fluid-mechanically connected to pressure sensor device 16. If catheter interface 8 is configured as a simple valve, connection point 28 is not provided. In this case, pressure may be measured before or after catheter interface 8.

[0055] The controller 18 is at least signal connected to the fluid supply device 12 and the pressure sensor device 16. Preferably, the fluid supply device 12 and the pressure sensor device 16 are also powered via the controller 18.

[0056] The operating devices 20, 22 are designed to allow a person to give control commands or specifications to the control device 18 and to receive status information of the device 4. For this purpose, the operating device 20 is connected to the control device 18 via a cable, at least by a signal. The operating device 20 can also be connected to the control device 18 so that the operating device 20 is or can be powered via the control device 18. The operating device 22 is connected or connectable to the control device 18 wirelessly.

[0057] In the state shown in FIG. 1, the balloon 30 of the balloon catheter 6 is filled with a fluid.

[0058] The pressure prevailing in the balloon 30 can be determined by the pressure sensor device 16, which is in fluid communication with the balloon 30 via connection points 24, 28 of the catheter interface 8 and the three-way valve 10, respectively. In the system according to the first embodiment, the pressure sensor device 16 is designed as a single pressure sensor.

[0059] The pressure determined by the pressure sensor device 16 may be output by the control device 18, the operating devices 20 and / or 22 and their respective output devices, for example in the form of a display.

[0060] By means of the operating device 20 or 22 a threshold and / or target value for the pressure determined by the pressure sensor device 16 can be specified.

[0061] The controller 18 is designed to control the feeder 12 according to specified thresholds and / or target values.

[0062] If the pressure in the balloon 30 determined by the pressure sensor device 16 is less than the target value, the control device 18 activates the fluid supply device 12 so that fluid flows from the fluid supply device 12 through the connection points 26, 24 of the catheter interface 8 to the balloon catheter 6 and the balloon 30, respectively.

[0063] If the pressure in the balloon 30 determined by the pressure sensor device 16 is above the target value and below the threshold value, the control device 18 drives the fluid supply device 12 so that fluid does not flow from or to the balloon catheter 6 and balloon 30, respectively.

[0064] If the pressure in the balloon 30 determined by the pressure sensor device 16 is greater than a threshold value, the control device 18 drives the fluid supply device 12 so that fluid flows from the balloon 30 and the balloon catheter 6, respectively, through the connection points 24 and 26 of the catheter interface 8 to or into the fluid supply device 12.

[0065] 2 shows a schematic diagram of the fluid supply device 12. The fluid supply device 12 includes a piston syringe 14 and a motor device or motor 32.

[0066] The piston syringe 14 includes a hollow cylinder 34 having a peripheral wall 36. The hollow cylinder 34 is open on one side and has a front wall 38 on the side opposite the open side. A piston 40 is inserted into the open side of the hollow cylinder 34. The piston 40 is displaceable within the hollow cylinder 34 and, together with the peripheral wall 36 and the front wall 38, encloses a fluid chamber 42. The size of the fluid chamber 42 is variable depending on the displacement of the piston 40 relative to the hollow cylinder 34.

[0067] The front wall 38 is formed with a fluid outlet 44. The fluid outlet 44 is fluid-mechanically connected to the connection points 26 of the catheter interface 8 and the three-way valve 10, respectively.

[0068] As the piston 40 moves toward the front wall 38, fluid in the fluid chamber 42 is transported through the fluid outlet 44 to the connection point 26, or more specifically, the catheter interface. This movement of the piston 40 toward the front wall 38 causes fluid to be expelled at the catheter interface 8, or more specifically, at the connection point 24 thereof.

[0069] When the piston 40 moves away from the front wall 38, a negative pressure is created at the fluid outlet 44, which acts to draw fluid from the connection point 26 and the catheter interface 8, respectively, and thus fluid is drawn into the catheter interface 8, or more specifically at its connection point 24. When the balloon catheter 6 is connected to the catheter interface, when the piston moves away from the front wall, fluid is drawn from the balloon catheter 6, or more specifically from the balloon 30, into the connection point 24.

[0070] A seal 52 for sealing the fluid chamber 42 is provided on the outer peripheral surface of the piston 40 between the piston 40 and the peripheral wall 36 of the hollow cylinder 34 .

[0071] A piston rod 54 connected to the piston 40 is provided on the side of the piston 40 facing away from the front wall 38. An external thread 56 is formed on the piston rod 54 at the end of its outer periphery facing away from the piston 40. Two gears 58, 60, which engage with the external thread 56 and are part of the motor 32, are arranged on either side of the external thread 56.

[0072] Gears 58, 60 are formed or adjusted with external threads 56 so that counter-rotation of gears 58, 60 causes translational movement of piston rod 54, or more specifically piston 40. Axes of rotation 62, 64 extend perpendicular to the axial or longitudinal axis of piston rod 54. Rotation of gears 58, 60 is caused by operation of motor 32.

[0073] The front side of the piston rod 54, facing away from the piston 40, is provided with a coupling 66, by which the piston rod 54 can move relative to the hollow cylinder 34. When the coupling 66 is rotated by a motor (specifically by the motor 32 connected to the coupling 66) while the gears 58, 60 are stationary, the engagement of the gears 58, 60 on the external thread 56 causes the piston rod 54 to move relative to the rotation axes 62, 64 of the gears 58, 60. The gears 58, 60 and the coupling 66 are all driven by the motor 32. Alternatively, the device 12 can be designed so that the gears 58, 60 and / or the coupling 66 are each driven by a separate motor.

[0074] To determine the position of the piston 40 relative to the hollow cylinder 34, the device 4 has a position sensor 68 connected by a signal to the controller 18 (see FIG. 1). Based on the change in position of the piston 40, the controller 18 can determine the amount of fluid to expel or withdraw.

[0075] 3 is a schematic diagram of a system 102 according to a second embodiment of the present invention. The system 102 according to the second embodiment differs from the system 2 according to the first embodiment only in that the system 102 according to the second embodiment has only a wired operation device 20 and does not have a wireless connection operation device 22.

[0076] 4 shows a schematic diagram of a system 202 according to a third embodiment of the present disclosure. The system 202 according to the third embodiment differs from the system 2 according to the first embodiment only in that the system 202 according to the third embodiment includes only a wireless connection operation device 22 and does not include a wired operation device 20.

[0077] 5 shows a schematic diagram of the operating device 22 according to the first embodiment. The operating device 22 is designed in the form of a tablet having a touch screen 70. The operating device 22 displays on the touch screen 70 a field 72 in which a pressure value is displayed, a field 74 in which a diameter value of the balloon catheter 6 is displayed, and a field 76 in which a slide switch is displayed. The operating device 22 is configured so that the value of one of the fields 72 or 74 can be changed by first touching one of the fields 72 or 74 to activate it (see field 72 in FIG. 5 ), and then swiping along field 76 to change the value of the activated field.

[0078] 6 shows a schematic diagram of an operating device 1022 according to a second embodiment. The operating device 1022 is designed as a slide switch and has a slide 1078 movable along a linear guide 1080. The operating device 1022 is adapted to determine a threshold or target value for the pressure measured by the pressure sensor device 16 by moving the slide 1078 along the linear guide 1080 of the control device 18.

[0079] 7 shows a schematic diagram of an operating device 2022 according to a third embodiment. The operating device 2022 is designed in the form of a compressible ball. The operating device 2022 is adapted to determine a threshold or target value for the pressure measured by the pressure sensor device 16, corresponding to the degree of compression of the control device 18.

[0080] 5, 6 and 7 are designed as wireless operating devices. Alternatively or additionally, the operating devices 22, 1022, 2022 can be configured to be connected to the control device 18 by electrical wires.

[0081] 8 shows a schematic diagram of a system 302 according to a fourth embodiment of the present invention. The system 302 according to the third embodiment differs from the systems 2, 102, 202 according to the first to third embodiments only in that the system 302 according to the fourth embodiment comprises a fluid-mechanical (i.e., hydraulic or pneumatic) operating device 3022 instead of the electric or electronic operating device 20, 22, 1022, or 2022, and corresponding to the fluid-mechanical operating device 3022, a pressure connection 378 and a pressure sensor 380 that is fluid-mechanically connected to the pressure connection 378 and that is connected by a signal to the control device 18. Preferably, the pressure sensor 380 is designed as a part of the pressure sensor device 316 according to the present disclosure.

[0082] The pressure connection 378 is adapted to be connected to an operating device 3022 .

[0083] FIG. 9 is a schematic diagram of a fluid machine operating device 3022 according to the first embodiment.

[0084] The operating device 3022 is designed in the form of a manual inflation syringe 3024 .

[0085] The inflation syringe 3024 includes a hollow cylinder 3026 having a peripheral wall 3028. The hollow cylinder 3026 is open on one side and has a front wall 3030 on the side opposite the open side. A piston 3032 is inserted into the hollow cylinder 3026 on the open side of the hollow cylinder 3026. The piston 3032 is displaceable in the hollow cylinder 3026 and, together with the peripheral wall 3028 and the front wall 3030, surrounds a fluid chamber 3034. The size of the fluid chamber 3034 is variable depending on the displacement of the piston 3032 relative to the hollow cylinder 3026.

[0086] The front wall 3030 is formed with a fluid outlet 3036 which represents a control fluid interface according to the present disclosure. The fluid outlet 3036 is fluid-mechanically connected or connectable to a pressure connection 378.

[0087] As the piston 3032 moves toward the front wall 3030, fluid (i.e., a control fluid as disclosed) in the fluid chamber 3034 is conveyed through the fluid outlet 3036 to the pressure connection 378. This movement of the piston 40 toward the front wall 3030 increases the pressure at the pressure connection 378.

[0088] As the piston 3032 moves away from the front wall 3030 , a negative pressure is created at the fluid outlet 3036 which draws fluid through the pressure connection 378 , thus reducing the pressure at the pressure connection 378 .

[0089] A seal 3038 that seals the fluid chamber 3034 is provided on the outer circumferential surface of the piston 3032 between the piston 3032 and the wall 3028 of the hollow cylinder 3026 .

[0090] A piston rod 3040 connected to the piston 3032 is provided on the side of the piston 3032 facing away from the front wall 3030. An external thread 3042 is formed on the piston rod 3040 at the end of its outer periphery facing away from the piston 3032. A screw block 3044 is connected to the hollow cylinder 3026 via a tilt lever 3046 on the side of the hollow cylinder 3026 facing away from the front wall 3030. The screw block 3044 is articulated or pivotally connected to the tilt lever 3046, which in turn is articulated or pivotally connected to the hollow cylinder 3026. The screw block 3044 has a threaded portion 3048 on the side facing the external thread 3042 of the piston rod (see FIG. 10 ), the threaded portion 3048 being configured to engage with the external thread 3042. The threaded block 3044 and the tilt lever 3046 together form a quick release valve that is designed to be moved by the tilt lever 3046 to an inactive position (see FIG. 9 ) in which the threaded block 3044 or its threaded portion 3048 engages the external threads 3042, and to an active position (see FIG. 10 ) in which the threaded block 3044 or its threaded portion 3048 does not engage the external threads 3042. Preferably, the quick release mechanism, or more specifically the tilt lever 3046, is preloaded by a spring (not shown) such that the quick release mechanism is preloaded to the inactive position and can only be moved to the active position by overcoming the preload.

[0091] A rotating handle 3050 is provided on the front side of the piston rod 3040, facing away from the piston 3032, by means of which the piston rod 3040 can be manually moved relative to the hollow cylinder 3026. When the rotating handle 3050 is manually turned (see arrow in FIG. 9 ) while the quick release valve is inactive, the engagement of the threaded portion 3048 on the outer thread 3042 causes the piston rod 3040 to be moved relative to the screw block 3044 and thus the hollow cylinder 3026. When the quick release is in the active position, the engagement between the screw block 3044 and the outer thread 3042 is released, so that the piston rod 3040, and thus the piston 3032, can be moved axially particularly quickly by moving the rotating handle 3050 in the axial direction of the piston 3032 (see double arrow in FIG. 10 ).

[0092] To operate the device 4 of the system 302 by means of the operating device 3022, the size of the fluid chamber 3034 is changed by changing the axial position of the piston 3032 relative to the hollow cylinder 3026 by means of the rotary handle 3050 (using a quick-release valve, either active or inactive), thereby changing the pressure of the fluid at the fluid outlet 3036 and therefore at the pressure connection 378. This pressure change is measured by the pressure sensor 380. The control device 18 of the device 4 of the system 302 is designed to convert the pressure measured at the pressure connection 378, or more specifically the pressure change measured at the pressure connection 378, into a control command for the motor 32 of the fluid supply device 12, which generates a corresponding pressure, or more specifically a pressure change, in the balloon catheter 6. By "conversion" it is meant in particular that the pressure generated by the fluid supply device 12 is higher than the pressure generated manually by the operating device 3022 and / or that the pressure curve generated by the fluid supply device 12 is smoother compared to the pressure curve generated manually by the operating device 3022.

[0093] 11 is a schematic diagram of a fluid machine operation device 4022 according to a second embodiment of the present disclosure. The fluid machine operation device 4022 according to the second embodiment differs from the fluid machine operation device 3022 according to the first embodiment in that the tilt lever 4046 of the fluid machine operation device 4022 according to the second embodiment is connected to a trigger 4052 in an articulated or pivoted manner. The provision of the trigger 4052 makes it possible to provide a pistol grip (not shown) on the inflation syringe 4024 of the operation device 4022, thereby improving the operability of the operation device 4022. Apart from the above differences, the fluid machine operation device 4022 according to the second embodiment corresponds to the fluid machine operation device 3022 according to the first embodiment.

[0094] Figure 12 shows a schematic diagram of a fluid machine operating device 5022 according to a third embodiment with the quick release valve in the inactive position. Figure 13 shows a schematic diagram of a fluid machine operating device 5022 according to a third embodiment with the quick release valve in the active position.

[0095] The fluid machine operating device 5022 according to the third embodiment is distinguished from the fluid machine operating device 3022 according to the first embodiment in that the screw block 5044 is formed as an eccentric wheel and is rotatably attached to the hollow cylinder 5024 so that the rotation axis of the screw block 5044 is parallel to the longitudinal axis of the piston rod 5040. The screw block 5044 has an opening 5054 through which the piston rod 5040 extends.

[0096] The opening 5054 is formed eccentrically so that the inner surface of the opening 5054, formed as the threaded portion 5048, engages with the external threads 5042 (see FIG. 12) of the piston rod 5040 when the screw block 5044 is in a first position relative to the hollow cylinder 5024 (see FIG. 12), and does not engage with the external threads 5042 of the piston rod 5040 when the screw block 5044 is in a second position offset relative to the hollow cylinder 5024 compared to the first position (see FIG. 13).

[0097] In the fluid machine operating device 5022 according to the third embodiment, the quick release mechanism is thus formed only by the screw block 5044. There is no need for a tilt lever like the fluid machine operating devices 3022 and 4022 according to the first and second embodiments.

[0098] Except for the above differences, the fluid machine operation device 5022 according to the third embodiment corresponds to the fluid machine operation device 3022 according to the first embodiment. [Explanation of symbols]

[0099] 2: System according to the first embodiment 4: Equipment 6: Balloon catheter 8: Catheter interface 10: Three-way valve 12: Fluid supply device 14: Piston syringe 16: Pressure sensor device 18: Control device 20:Wired operating device 22: Wireless connection operation device 24: Catheter side connection point of three-way valve 26: Three-way valve fluid supply side connection point 28: Three-way valve pressure sensor connection point 30: Balloon 32: Motor of fluid supply device 34: Hollow cylinder of piston syringe 36: Piston syringe peripheral wall 38: Front wall of piston syringe 40: Piston of piston syringe 42: Fluid chamber of piston syringe 44: Fluid outlet of piston syringe 52: Piston-to-wall seal 54: Piston rod 56: Piston rod external thread 58,60: Motor gears 62,64: Rotation axis 66: Coupling part on piston rod 68: Position sensor 70: Touchscreen 72-76: Touchscreen fields 102: System according to the second embodiment 202: System according to the third embodiment 302: System according to the fourth embodiment 378: Pressure connection 380: Pressure sensor 1022: Operating device according to the second embodiment 1078: Slide 1080: Linear guide 2022: Electric operating device according to the third embodiment 3022: Fluid machine operating device according to the first embodiment 3024: Inflation syringe 3026: Hollow cylinder of inflation syringe 3028: Inflation syringe wall 3030: Front wall of inflation syringe 3032: Inflation syringe piston 3034: Fluid chamber of inflation syringe 3036: Fluid outlet of inflation syringe 3038: Piston-to-wall seal 3040. Piston rod 3042: Piston rod external thread 3044: Screw block 3046: Tilt lever 3048:Threaded part 3050: Rotating handle on piston rod 4022: Fluid machine operating device according to the second embodiment 4024: Inflation syringe 4032: Inflation syringe piston 4046: Tilt lever 4052: Trigger 5022: Fluid machine operating device according to the third embodiment 5024: Hollow cylinder of inflation syringe 5032: Inflation syringe piston 5040: Piston rod 5042: External thread 5044: Screw block 5048:Threaded part 5054: Opening

Claims

1. A device (4) for automatically inflating a vascular balloon catheter (6), in particular an angioplasty catheter, with a fluid, comprising: a catheter interface (8), a fluid supply device (12), a pressure sensor device (16), and a control device (18); the catheter interface (8) is specially designed to be removably connectable to the balloon catheter (6) without tools, so that the fluid can flow from the device (4) through the catheter interface (8) to the balloon catheter (6); the fluid supply device (12) is designed to expel the fluid from the device (4) at the catheter interface (8) by means of a motor (32); the pressure sensor device (16) is designed to measure the pressure of the fluid discharged from the device (4); the control device (18) is designed to control the amount of fluid discharged from the device (4) by the fluid supply device (12) by driving the motor (32) of the fluid supply device (12) based on the pressure measured by the pressure sensor device (16); The device (4) is characterized in that the fluid supply device (12) is designed at the catheter interface (8) so that the fluid can be drawn into the device (4) by the motor (32).

2. the control device (18) is designed to draw in the fluid by the fluid supply device (12) when a predetermined threshold value of the pressure measured by the pressure sensor device (16) is exceeded.

2. The device (4) according to claim 1.

3. the control device (18) is adapted to prevent the fluid from being drawn in by the fluid supply device (12) after the predetermined threshold has been exceeded and after a subsequent drop in the pressure measured by the pressure sensor device (18) when the predetermined threshold is reached again.

3. The device (4) according to claim 2.

4. the fluid is a liquid, and the device (4) comprises an exhaust device (46) by means of which gas mixed with the liquid can be exhausted from the device (4), 4. A device (4) according to any one of claims 1 to 3.

5. The control device (18) is capable of controlling the fluid supply device (12) so that the fluid is supplied at different predetermined supply rates.

5. An apparatus (4) according to any one of claims 1 to 4.

6. the control device (18) is designed to adjust the fluid supply device (12) depending on the pressure measured by the pressure sensor device (16), in particular to reach at least two different predetermined pressure levels.

6. An apparatus (4) according to any one of claims 1 to 5.

7. characterized by an energy storage device for storing electrical energy so that excess pressure can be reduced and a vacuum can be generated in the event of a power outage; 7. An apparatus (4) according to any one of claims 1 to 6.

8. the motor (32) of the fluid supply device has tensioning means designed to tension when the fluid is expelled and to relax when the fluid is retracted, 7. An apparatus (4) according to any one of claims 1 to 6.

9. the control device (18) has a data interface that allows data to be transferred to and / or from a smartphone, tablet or other device, 9. An apparatus (4) according to any one of claims 1 to 8.

10. the device (4) comprises an operating device (20; 22; 1022; 2022; 3022; 4022; 5022) connected to the data interface and capable of receiving control commands from a person and transferring said control commands to the control device (18), 10. The device (4) according to claim 9.

11. the operating device (3022; 4022; 5022) is designed in the form of a manual inflation syringe, 11. The device (4) according to claim 10.

12. said operating device (3022; 4022; 5022) being an inflation syringe (3024; 4024; 5024) by means of which a control fluid can be delivered to a control fluid interface of said inflation syringe (3024; 4024; 5024) by movement of a piston (3032; 4032; 5032); said data interface being designed as a pressure connection (378) that can be connected to said control fluid interface of said inflation syringe (3024; 4024; 5024); the pressure sensor device (316) is designed to measure the pressure of the control fluid at the pressure connection (378); the control device (18) is designed to control the fluid supply device (12) in response to the pressure of the control fluid measured at the pressure connection (378); characterized in that 12. The device (4) according to claim 11.

13. the operating device (22) has a display (70) designed to display status data of the device (4), 13. Apparatus (4) according to any one of claims 10 to 12.

14. A system (2; 102; 202; 302) for performing angioplasty, comprising a balloon catheter (6) and a device (4) according to any one of claims 1 to 13.

15. The device (4) is designed to generate a negative pressure or vacuum in the balloon catheter.

15. The system (2; 102; 202; 302) according to claim 14.

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